Med-tech M&A activity rebounded in April, reaching $1.4 billion, a sharp increase from March’s $22.63 million, though still down from nearly $5 billion in January and $6 billion in February.

Device makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone.

The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.

Despite the uncertain macro environment created by the threat of reciprocal tariffs on goods into the U.S., some investors are still upbeat about the med tech sector. Even with changes at the HHS and disruption to product approvals throughout the FDA, venture capital investors remain cautiously optimistic.

The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.

The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.